EP3151013B1 - Automatic analysis device - Google Patents

Automatic analysis device Download PDF

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Publication number
EP3151013B1
EP3151013B1 EP15799548.1A EP15799548A EP3151013B1 EP 3151013 B1 EP3151013 B1 EP 3151013B1 EP 15799548 A EP15799548 A EP 15799548A EP 3151013 B1 EP3151013 B1 EP 3151013B1
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EP
European Patent Office
Prior art keywords
analysis
check
display
screen
check item
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
EP15799548.1A
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German (de)
English (en)
French (fr)
Other versions
EP3151013A1 (en
EP3151013A4 (en
Inventor
Hirofumi Sasaki
Toshihide HANAWA
Tsuguhiko SATOU
Yoshihiro Naitou
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Hitachi High Tech Corp
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Hitachi High Tech Corp
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Publication of EP3151013A1 publication Critical patent/EP3151013A1/en
Publication of EP3151013A4 publication Critical patent/EP3151013A4/en
Application granted granted Critical
Publication of EP3151013B1 publication Critical patent/EP3151013B1/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G01N35/025—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations having a carousel or turntable for reaction cells or cuvettes
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00594—Quality control, including calibration or testing of components of the analyser
    • G01N35/00712—Automatic status testing, e.g. at start-up or periodic
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/02—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor using a plurality of sample containers moved by a conveyor system past one or more treatment or analysis stations
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N2035/00465—Separating and mixing arrangements
    • G01N2035/00534—Mixing by a special element, e.g. stirrer
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N2035/00891—Displaying information to the operator
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
    • G01N35/00584—Control arrangements for automatic analysers
    • G01N35/00722—Communications; Identification
    • G01N2035/00891—Displaying information to the operator
    • G01N2035/0091—GUI [graphical user interfaces]

Definitions

  • the present invention relates to an automatic analysis device.
  • An automatic analysis device includes an analysis unit that has a mechanism system for measuring the concentration of a test substance in a sample, and an operation control unit.
  • a test substance in a sample such as blood, urine, a body fluid, and the like is mixed with a reagent with respect to the test substance, inside a reaction container.
  • a generated reactant is irradiated with light and the absorbance thereof is measured.
  • a quantitative analysis of the test substance is performed, and a measurement value is converted into concentration and a result thereof is output.
  • a start-up inspection screen is displayed. As the start-up inspection, each unit of the device is visually inspected before power is turned on. Power is supplied to the automatic analysis device after opening a faucet of tap water and turning on power of a pure water device.
  • the state of the device is confirmed based on the presence or absence of issuance of an alarm, and maintenance such as water exchange of a reaction tank, a photometer check, reagent priming, and the like is performed.
  • the water temperature of the reaction tank, the quantity of light of the photometer, and a relieved state of low-reagent inside a reagent flow channel are confirmed through the presence or absence of issuance of an alarm or visual recognition.
  • a measurement result of a sample measured on the previous day is deleted, and a reagent, a detergent, and a dilute solution required for measuring the sample on the day are prepared and are set to the device, thereby starting an analysis of the sample.
  • the device automatically performs a consistency check of an analysis method and analysis parameters such as prozone parameters, calibration parameters, and the like, thereby starting the analysis only when all of the analysis parameters are normally set. In a case where there is an error or inconsistency in the set analysis parameters, an alarm is issued and the analysis is stopped.
  • the document US 2009/0263281 A1 discloses an automatic analyzer configured to display a re-measurement request screen upon detecting an unusual condition.
  • the re-measurement request screen includes a checklist to be checked by the operator to overcome the unusual condition and to perform a re-measurement.
  • the document US 2013/0287593 A1 discloses a further apparatus configured to display a checklist and the document JP 2013 076619 discloses an apparatus configured to display a checklist, wherein some check boxes are automatically checked.
  • PTL 1 discloses an example of start-up inspection of an automatic analysis device.
  • a check which is automatically performed by a device at the time of an analysis start of a sample is mainly a consistency check for an analysis parameter.
  • Other check items before the analysis start are required to be directly confirmed by an operator through the presence or absence of issuance of an alarm, or visual recognition.
  • a difference is generated in the contents to be checked before the analysis start. For example, in a case where the operator is a person such as a night shift who is not skilled in handling the device, a check item before the analysis start is likely to be missed.
  • An object of the present invention is to realize an automatic analysis device in which the check item at the time of the analysis start can be set in accordance with the skill level of an operator, the analysis can be performed after the check item is displayed and confirmed, and erroneous measurement caused due to a missed check can be prevented.
  • the present invention proposes an automatic analysis device according to claim 1.
  • Fig. 1 is a schematic view in principle illustrating an overall configuration of an automatic analysis device in which the example of the present invention is applied.
  • the reference sign 101 indicates an operation control unit.
  • the operation control unit 101 is a computer including peripheral instruments such as a keyboard 102 for inputting data, a mouse 103, a display device 104 for displaying data, a printing device 105 for printing data, an interface 106 for being connected to an analysis unit, a storage device 107 for storing analysis instruction information and measurement results, and the like.
  • the reference sign 108 indicates the analysis unit, which is connected to the operation control unit 101 via the interface 106.
  • the reference sign 109 indicates a reaction disk, and multiple reaction containers 110 are installed on the concentric circumference thereof.
  • the reference sign 111 indicates reagent bottles respectively containing various types of reagent, and a reagent suctioning tube 112 is connected to the bottle mouth thereof leading to a low-reagent sensor 125.
  • a sample dispensing mechanism 113, a stirring device 114, a cleaning device 115, a light source 116, and a multi-wavelength photometer 117 are individually disposed.
  • a reagent dispensing mechanism 118 is disposed and a reagent which has passed through the reagent suctioning tube 112 is supplied to the reagent dispensing mechanism 118.
  • a rack conveyance line 119 is installed on the rotation circumference of the sample dispensing mechanism 113.
  • a rack 120 moves on the rack conveyance line 119.
  • Multiple sample containers 121 respectively containing samples are laid in the rack 120.
  • An operator gives an analysis instruction by using the display device 104, the keyboard 102, or the mouse 103 of the operation control unit 101.
  • the analysis instruction is stored in the storage device 107 and is transmitted to the analysis unit 108 via the interface 106.
  • the analysis unit 108 performs an analysis operation as follows.
  • the sample dispensing mechanism 113 dispenses a sample contained in the sample container 121 to the reaction container 110 as much as a predetermined quantity.
  • the rack 120 moves on the rack conveyance line 119 such that the next sample container 121 comes to a place immediately below the sample dispensing mechanism 113.
  • the rack 120 moves on the rack conveyance line 119 so as to be conveyed out.
  • the reaction container 110 having the dispensed sample rotatively moves on the reaction disk 109 due to a rotative operation of the reaction disk 109.
  • the reagent dispensing mechanism 118 dispenses the reagent inside the reagent bottle 111 to the sample in the reaction container 110
  • the stirring device 114 stirs a reaction liquid
  • measurement of absorbance is performed by the light source 116 and the multi-wavelength photometer 117.
  • the reaction container 110 brought to an end of the analysis is cleaned by the cleaning device 115.
  • a measured absorbance signal is input to the computer 123 via an A/D converter 124 and the interface 122.
  • the absorbance signal based on an analysis method which has been previously set for each test substance, in a case of a standard liquid sample, calibration curve data is calculated from set concentration data, and in cases of a patient sample and a control sample, the concentration data is calculated from the calibration curve data obtained through measurement of the standard liquid sample. As the measurement result, these pieces of data are subjected to addition of information in which the types of sample are symbolized. Thereafter, the data is transmitted to the operation control unit 101 via the interface 106.
  • the operation control unit 101 stores the received measurement result in the storage device 107 and outputs the measurement result to the display device 104 and the printing device 105.
  • Fig. 18 is a flow chart illustrating the flow of the processing of the inspection and the like performed before measurement starts.
  • Step S1 of Fig. 18 the operator performs inspection of the operation control unit, a sample conveyance unit, and the analysis unit.
  • Step S2 the operator runs tap water and turns on power.
  • Step S3 the operator confirms the condition of the device and performs maintenance.
  • the operator confirms an alarm, performs confirmation of circumstances and execution of maintenance, confirms air bubbles inside a flow channel, performs reagent priming, performs water exchange and temperature confirmation of a reaction tank, and confirms the condition of discharging cleaning water.
  • an alarm screen, a maintenance screen, and a printing screen displayed through the display device 104 are used.
  • Step S4 the operator deletes the measurement result of the previous day by using a measurement result screen.
  • Step S5 the operator prepares the reagent, a detergent, and a dilute solution.
  • the operator confirms the reagent, the detergent, and the dilute solution to be supplemented.
  • the operator sets a colorimetric analysis reagent, the detergent, and the dilute solution.
  • the operator sets an electrolyte analysis reagent and installs a detergent bottle for reaction cells.
  • a system overview or reagent management/circumstances screen, the printing screen, a reagent management/setting screen, and the maintenance screen are used.
  • Step S6 is an analysis start processing step, which is a step in which calibration is performed, an accuracy management specimen is measured, and the measurement result is confirmed.
  • the operator performs the calibration, registers a request item of the accuracy management specimen, prepares a standard liquid and the accuracy management specimen, sets the standard liquid and the accuracy management specimen to the rack, and gives an instruction to start measurement. Then, the operator confirms the measurement result.
  • measurement of the calibration and the accuracy management specimen is automatically performed by the automatic analysis device in accordance with set conditions.
  • the operator gives an instruction of starting measurement by using a start screen.
  • Step S7 the patient sample is measured.
  • the operator registers the request item of the patient sample, prepares the patient sample, sets the patient sample to the rack, and gives an instruction to start measurement.
  • the operator gives an instruction by using an item selection screen and the start screen.
  • a confirmation item (check item which is to be checked before an analysis operation) required to be displayed in the start screen in which an instruction to start measurement is given at the time of the analysis start in Step S6 can be set for each type of operator. According to the configuration, when the set confirmation item is not checked, measurement is inhibited from starting, in principle.
  • Fig. 2 is a view illustrating a check item setting list screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • Fig. 2 is a screen for setting the confirmation item required to be displayed, in accordance with the type of operator or the like.
  • a check name is displayed in the corresponding line of check item setting information No. 201 in a check item setting information list 202.
  • the check name is a name of the check item setting information which is registered in a check item setting screen described below.
  • the check item setting screen ( Fig. 3 ) is displayed.
  • the line displaying the check name in the list 202 is selected and a delete button 204 is pressed, the check item setting information of the selected check name is deleted.
  • the delete button 204 is in an inactive display state and cannot be pressed.
  • Fig. 3 is the check item setting screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention. As described above, this screen is displayed by pressing the edit button 203 of Fig. 2 . In a case where the line displaying the check name in the check item setting list 202 illustrated in Fig. 2 is selected and the edit button 203 is pressed, the check item setting information ( Fig. 3 ) of the check name retained in the storage device 107 is displayed in the screen. In a case where a line displaying no check name in the list 202 of Fig. 2 is selected and the edit button 203 is pressed, a check item setting screen for new registration is displayed.
  • the operator sets a check name 301 as the check item setting information.
  • a target user 302 is set.
  • any one of designating a user level such as operator, supervisor, and administrator, and designating a user ID can be selected.
  • a day/time zone setting button 303 is pressed, a day/time zone setting screen described below is displayed.
  • a maintenance period check 304 is set.
  • the operator checks the maintenance period check 304, if there is an item exceeding a maintenance period among maintenance items which are set so as to be required to be checked at the time of the analysis start in a maintenance period setting screen described below, the item is displayed in the analysis start screen described below, as a preset check item previously prepared in the device.
  • the operator can set a selective check 305, the number 307 of consecutive times, and a time-out value 308 for each preset check item 306.
  • the preset check item 306 itself cannot be edited.
  • the selective check 305 is checked, the selective check 305 is displayed in the analysis start screen as the preset check item.
  • the number 307 of consecutive times is used in a case of a check item which is no longer necessary to be displayed in the screen at the time of the analysis start in the middle of the process because the check item is habituated as routine work such as supplement of the reagent before the analysis start.
  • the check item of which the number of times of consecutive checks performed by the same operator at the time of the analysis start has reached the number 307 of consecutive times is not displayed in the analysis start screen thereafter, in a manner similar to a case where the selective check 305 is unchecked.
  • the time-out value 308 is used as the maximum time of a waiting time of the check item which automatically starts after waiting until the water temperature of the reaction tank, the quantity of light of a photometer, or the like reaches a value within a specification, after a analysis start button described below is pressed, and the maximum number of times of the repetitive number of times of a reagent priming operation when the reagent priming operation automatically starts after waiting until a low-reagent state of the reagent is relieved, similarly after the analysis start button is pressed.
  • the alarm is configured to be displayed in an alarm display screen described below so as not to start an analysis.
  • a check item 310 to be set by a user in the check item setting screen, a check item 310 to be set by a user (operator), a selective check 309, and the number 311 of consecutive times are set.
  • the check item 310 to be set by the user can be freely edited by the operator.
  • the selective check 309 is checked, the selective check 309 is displayed in the below-described analysis start screen as a user setting check item.
  • the number 311 of consecutive times has a function similar to that of the number 307 of consecutive times.
  • check item setting screen when the operator presses a registration button 313, set check information is retained in the storage device 107, and the screen is closed. In addition, in a case where a cancel button 312 is pressed, the screen is closed without retaining the set check information in the storage device 107.
  • Fig. 4 is the day/time zone setting screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • the day/time zone setting screen is displayed when the day/time zone setting button 303 of Fig. 3 is pressed.
  • day/time zone setting information therein is displayed in the screen.
  • day/time zone setting information for new registration is displayed in the screen.
  • the day and the time zone in which the check item setting information is displayed in the analysis start screen at the time of the analysis start is set.
  • the day is designated with a day selective check 401
  • the time zone of each day is designated with a time zone designation pulldown list 402.
  • Fig. 5 is the maintenance period setting screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • the maintenance item selected from a maintenance item list 501 of the configuration unit of the automatic analysis device in a case where maintenance period setting information is already retained in the storage device 107, the information is displayed in the screen.
  • a display for new registration is provided in a case where the maintenance period setting information is not retained in the storage device 107.
  • a value 502 of the maintenance period, a unit 503 (time/date/month) of the maintenance period, the counting method (real time, power-on, operation) 504 of the maintenance period, and a check 505 at the time of the analysis start are set.
  • the operation control unit 101 determines whether or not the maintenance item has exceeded the maintenance period at the time of the analysis start. Even though maintenance item has exceeded the maintenance period, when the maintenance is not executed, in a case of the check item setting information of which the maintenance period check 304 is checked in the check item setting screen described in Fig. 3 , the name of the maintenance item is displayed in the analysis start screen as the preset check check item.
  • a registration button 507 illustrated in Fig. 5 When a registration button 507 illustrated in Fig. 5 is pressed, the set maintenance period setting information is retained in the storage device 107, and the screen is closed. In a case where a cancel button 506 is pressed, the screen is closed without retaining the set maintenance period setting information in the storage device 107.
  • Fig. 6 is the message list screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • a beginning portion of a message registered through a message input screen described below is displayed in a line of a reference sign 601 which is the corresponding message No. in a message list 602.
  • the message input screen is displayed.
  • the delete button 604 When a line displaying a beginning portion of a message is selected from the list 602 and a delete button 604 is pressed, the selected input message is deleted. In a case where a line displaying no beginning portion of a message is selected from the list 602, the delete button 604 is in an inactive display state and cannot be pressed.
  • Fig. 7 is the message input screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • This message input screen is displayed when the edit button 603 of Fig. 6 is pressed.
  • the input message information corresponding to the message No. 601 retained in the storage device 107 is displayed in the screen.
  • the message input screen for new registration is displayed.
  • a message transmission target user 701, a message 702, and a check 703 at the time of the analysis start are set.
  • the target user 701 any one of designating the user level such as operator, supervisor, and administrator, and designating the user ID can be selected.
  • the message 702 can be freely edited by the operator in a text inputting-type method.
  • the registered input message 702 can be confirmed in the analysis start screen by the operator corresponding to the transmission target user 701.
  • the check 703 at the time of the analysis start is checked, the analysis start cannot be carried out unless the operator confirms the message.
  • the input message information is retained in the storage device 107 and the screen is closed.
  • the screen is closed without retaining the input message information in the storage device 107.
  • Fig. 8 is the analysis start screen before execution of the check the check item, displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • Pieces of information in which the operator matches the set information of the set target user 302 and the date/time when the analysis start screen is opened match the set day/time zone 401 and 402 of Fig. 4 are respectively displayed in a preset check item list 802 and a user setting check item list 806 from the information set in the check item setting screen of Fig. 3 .
  • a checkbox is displayed in the column of a confirmation check 801.
  • an item which the device does not automatically check among the check items set in the check item setting screen can be checked by the operator through a manual input, and an item other than that cannot be manually input.
  • an execution button 803 can be pressed. In a case where the execution button 803 is pressed, the check or the maintenance is executed. In a case where the result of the check is OK, or the maintenance normally ends, the checkbox of the confirmation check 801 of the item is automatically checked.
  • an execution button 804 after start can be pressed.
  • the execution button 804 is pressed, the checkbox of the confirmation check 801 of the item at that timing is automatically checked.
  • the check or the maintenance is automatically executed after an analysis start button 808 is pressed.
  • the checkbox of the user setting check item can be checked by the operator through a manual input, and the checkbox of the message cannot be manually input.
  • a display button 807 can be pressed.
  • a received message display screen described below is displayed. After the received message display screen is closed, the message is presumed to be confirmed, and the checkbox of the confirmation check 805 of the message is automatically checked.
  • a received message can be deleted in the received message display screen, when the received message is deleted and the displaying returns to the analysis start screen before execution of the check, in a case where the message is selected on the lists 805 and 806, the display button 807 cannot be pressed.
  • the analysis start button 808 is in an inactive display state as illustrated, and cannot be pressed.
  • the operation control unit 101 determines whether or not checking is input by the operator for all of the checkboxes, and only when it is determined that checking is input for all of the checkboxes, the analysis operation is allowed to start.
  • an emergency start button 810 is prepared in case of circumstances where an analysis has to be immediately started due to an occurrence of an urgent sample, or the like.
  • the emergency start button 810 can be pressed even if the confirmation checks 801 and 805 are not checked. In a case where the emergency start button 810 is pressed, regardless of the presence or absence of the automatic checking after the analysis start button is pressed, an analysis is immediately started and the screen is closed.
  • the start waiting time can be a time after an analysis start button 908 is pressed or can be a time from a point of time other than that.
  • Fig. 9 is a view illustrating the analysis start screen after checking all of the check items displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • the reference signs 901 to 912 of Fig. 9 and the reference signs 801 to 812 of Fig. 8 indicate the same.
  • the analysis start button 908 (corresponding to the analysis start button 808 of Fig. 8 ) is in an active display state and can be pressed. Accordingly, a normal analysis start can be carried out.
  • the analysis start button 908 When the analysis start button 908 is pressed, an analysis, or automatic checking after the analysis start button is pressed starts, and the screen is closed. In addition, after the analysis start button 908 is pressed, at the timing when the analysis starts, the check information of the confirmation checks 901 and 905 is initialized.
  • Fig. 10 is the received message display screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • the received message display screen is displayed when the received message display button 807 of Fig. 8 is pressed.
  • a received message 1001 In the received message display screen, a received message 1001, a message sender's user ID 1002, and a message transmission date/time 1003 are displayed.
  • a cancel button 1004 when a cancel button 1004 is pressed, the screen is closed without deleting the displayed information of the received message from the storage device 107.
  • a delete button 1005 when a delete button 1005 is pressed, the displayed information of the received message is deleted from the storage device 107, and the screen is closed.
  • Fig. 11 is the alarm display screen displayed through the display device 104 of the operation control unit 101, according to the example of the present invention.
  • the alarm display screen is a screen for displaying contents as alarm information in a case where abnormality occurs while maintenance is executed with respect to a maintenance execution item after the analysis start button 908 is pressed or the automatic check item, the water temperature of the reaction tank, the quantity of light of the photometer, or the like does not reach the value within the specification even after waiting till the time-out value 308, or the low-reagent state of the reagent is not relieved.
  • alarm codes 1101 and 1106, an alarm generation site 1102, alarm levels 1103 and 1107, an alarm name 1104, an alarm generation date/time 1105, description of an alarm 1108, and countermeasures for an alarm 1109 are displayed.
  • Fig. 12 is a flow chart of depicting processing of the analysis start button in the analysis start screen executed by the operation control unit 101, according to the example of the present invention.
  • the depicting processing is activated when the analysis start screen is opened and the display of the analysis start screen is updated.
  • Step 1201 "HAVE ALL OF PRESET CHECK ITEMS BEEN CHECKED?" is determined in Step 1201. In a case of No, "DEPICT ANALYSIS START BUTTON IN INACTIVE STATE" is executed in Step 1204.
  • Step 1201 when all of the preset check items have been checked in Step 1201, that is, in a case of Yes, "HAVE ALL OF USER SETTING CHECK ITEMS BEEN CHECKED?" is determined in Step 1202. In a case of No, "DEPICT ANALYSIS START BUTTON IN INACTIVE STATE" is executed in Step 1204. In Step 1202, when all of the user setting check items have been checked, that is, in a case of Yes, "DEPICT ANALYSIS START BUTTON IN ACTIVE STATE" is executed in Step 1203.
  • Figs. 13 to Fig. 15 are a flow chart of analysis start activation determining processing.
  • the analysis start activation determining processing is activated when the analysis start button 908 or the emergency start buttons 810 and 910 are pressed.
  • Fig. 16 is a functional block diagram illustrating a function of setting the check item and a function of determining whether or not the displayed check item or the like is executed by the operator, among the functions which the operation control unit 101 has, according to the example of the present invention.
  • the above-described check item at the time of the analysis start is designated by using the keyboard 102 or the mouse 103, the designated check item is set through a unit 1010 for setting the check item at the time of the analysis start, and the set check item is stored in the storage device 107.
  • the set contents are read out from the storage device 107 by the unit 1010 for setting the check item at the time of the analysis start and is displayed through the display unit (the display device) 104. Instructions, data, and the like input by using the input units 102 and 103 are configured to be displayed through the display unit 104.
  • a check item execution confirmation unit 1011 When checking process at the time of the analysis start starts, a check item execution confirmation unit 1011 reads out the contents of the set check item from the storage device 107, in accordance with the instruction from the unit 1010 for setting the check item at the time of the analysis start.
  • the check item execution confirmation unit 1011 checks whether or not the operator has confirmed the check item, through the contents or the like displayed in the display unit 104.
  • the check item execution confirmation unit 1011 activates a timer 1012, thereby counting the start waiting time or the like.
  • the check item execution confirmation unit 1011 delivers an analysis start command to the computer 123 via the interfaces 106 and 122.
  • the operational flow chart in Figs. 13 to 15 mainly illustrates processing performed by the check item execution confirmation unit 1011.
  • Step 1301 "PRESSED IS EMERGENCY START BUTTON?" of Fig. 13 is determined in Step 1301. In a case of Yes, the process proceeds to Step 1325 illustrated in Fig. 15 so as to end the processing of "ACTIVATE ANALYSIS START PROCESSING".
  • Step 1301 of Fig. 13 in a case where "PRESSED IS EMERGENCY START BUTTON?" is No, "0 IS SET FOR FLAG” (Step 1302), and "IS MAINTENANCE CURRENTLY EXECUTED FOR AUTOMATIC CHECK ITEM?" is determined (Step 1304) as many times as "NUMBER OF TIMES OF SETTING AUTOMATIC CHECK ITEM AFTER ANALYSIS START BUTTON IS PRESSED" (Steps 1303 and 1306). Only in a case of Yes, "1 IS SET FOR FLAG" (Step 1305) is executed.
  • Steps 1304 and 1305 After ending the determination of the processing of Steps 1304 and 1305 performed as many times as "NUMBER OF TIMES OF SETTING AUTOMATIC CHECK ITEM AFTER ANALYSIS START BUTTON IS PRESSED" (Steps 1303 and 1306), "IS FLAG 0?" is determined (Step 1307). In a case of No, after "WAITING TIME OF 1 SECOND” (Step 1308), the process restarts from the processing Step 1302.
  • Step 1307 in a case where "IS FLAG 0?" is Yes, "HAS TIME-OUT TIME SET IN CHECK ITEM SETTING SCREEN REGARDING AUTOMATIC CHECK ITEM ELAPSED?" is determined (Step 1310) as many times as "the number of times of setting the automatic check item after the analysis start button is pressed" (Steps 1309 and 1313). Only in a case of Yes, "ALARM IS REGISTERED" (Step 1311), and "1 IS SET FOR FLAG” (Step 1312) is executed.
  • Step 1310 to 1312 After ending the determination of the processing of Steps 1310 to 1312 performed as many times as "NUMBER OF TIMES OF SETTING AUTOMATIC CHECK ITEM AFTER ANALYSIS START BUTTON IS PRESSED" (Step 1309 and 1313), "IS FLAG 0?" is determined (Step 1314). In a case of No, the processing ends.
  • Step 1314 in a case where "IS FLAG 0?" is Yes, "IS CHECK RESULT OF AUTOMATIC CHECK ITEM OK?" (Step 1316) is determined as many times as "NUMBER OF TIMES OF SETTING AUTOMATIC CHECK ITEM AFTER ANALYSIS START BUTTON IS PRESSED" (Step 1315 and 1320). Only in a case of No, "IS MAINTENANCE OF AUTOMATIC CHECK ITEM REQUIRED TO BE ACTIVATED?" (Step 1317) is determined. In a case of Yes, “MAINTENANCE OF AUTOMATIC CHECK ITEM IS ACTIVATED" (Step 1318), and “1 IS SET FOR FLAG” (Step 1319). In Step 1317, in a case where "IS MAINTENANCE REQUIRED TO BE ACTIVATED?" is No, "1 IS SET FOR FLAG” (Step 1319).
  • Step 1317 to 1319 After ending the determination of the processing of Steps 1317 to 1319 performed as many times as "NUMBER OF TIMES OF SETTING AUTOMATIC CHECK ITEM AFTER ANALYSIS START BUTTON IS PRESSED" (Step 1315 and 1320), "IS FLAG 0?" is determined (Step 1321). In a case of No, after "WAITING TIME OF 1 SECOND” (Step 1324), the process restarts from the processing Step 1302.
  • Step 1321 in a case where "IS FLAG 0?" is Yes, "IS THERE ANY SETTING FOR START WAITING TIME OF ANALYSIS START SCREEN?" is determined (Step 1322). In a case of No, "ANALYSIS START PROCESSING IS ACTIVATED" (Step 1325), and the processing ends.
  • Step 1322 in a case where "IS THERE ANY SETTING OF START WAITING TIME?" is Yes, "HAS START WAITING TIME ELAPSED?" is determined (Step 1323). In a case of No in Step 1323, after "WAITING TIME OF 1 SECOND" (Step 1324), the process restarts from the processing 1302.
  • Step 1323 in a case of Yes, "ANALYSIS START PROCESSING IS ACTIVATED" (Step 1325), and the processing ends.
  • Fig. 17 is a view illustrating an example of an output result of check item log information at the time of the analysis start.
  • the log information illustrated in Fig. 17 is retained in the storage device 107 by the operation control unit 101 for each term from the analysis start to the analysis end.
  • the log information is output to an external media such as the display device 104, the printing device 105, a USB, and the like based on the output instruction input through the input devices 102 and 103.
  • the output information is a title 1401 of the log information, an output date/time 1402 of the log information, a user ID 1403 of the operator who performed the analysis operation, a start time/end time of analysis 1404, a preset check item 1405 checked at the time of the analysis start, a user setting check item 1406 checked at the time of the analysis start, information 1407 of the number of measurement samples for the sample type and the analysis module, and the presence or absence 1408 of execution of cleaning maintenance at the time of the analysis end.
  • the check item such as checking the remaining quantity of a reagent or the like displayed in the check screen before the analysis start can be set for each type of operator, each day, each time.
  • the set check item is configured to be displayed in the screen before the analysis start, and unless the operator confirms the check item, the analysis start is not allowed in principle.
  • MULTI-WAVELENGTH PHOTOMETER 118 ... REAGENT DISPENSING MECHANISM, 119 ... RACK CONVEYANCE LINE, 120 ... RACK, 121 ... SAMPLE CONTAINER, 122 ... INTERFACE, 123 ... COMPUTER, 124 ... A/D CONVERTER, 125 ... LOW-REAGENT SENSOR, 202 ... CHECK ITEM SETTING INFORMATION LIST, 301 ... AREA FOR INPUTTING NAME OF CHECK ITEM TO BE SET, 302 ... AREA FOR SETTING TARGET USER OF CHECK ITEM TO BE SET, 303 ...

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  • Chemical & Material Sciences (AREA)
  • Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Biochemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Physics & Mathematics (AREA)
  • Immunology (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Quality & Reliability (AREA)
  • Plasma & Fusion (AREA)
  • Automatic Analysis And Handling Materials Therefor (AREA)
EP15799548.1A 2014-05-30 2015-04-07 Automatic analysis device Active EP3151013B1 (en)

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JP2014113028 2014-05-30
PCT/JP2015/060897 WO2015182256A1 (ja) 2014-05-30 2015-04-07 自動分析装置

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JP7064887B2 (ja) * 2018-01-12 2022-05-11 株式会社ディスコ 加工装置の管理方法および加工装置
JP7259859B2 (ja) * 2018-09-27 2023-04-18 株式会社島津製作所 バリデーション装置、バリデーション方法およびバリデーションプログラム
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JP7105530B2 (ja) * 2019-04-24 2022-07-25 株式会社日立ハイテク 自動分析装置および自動分析装置におけるメンテナンスガイド方法
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WO2015182256A1 (ja) 2015-12-03
JPWO2015182256A1 (ja) 2017-04-20
US20170212137A1 (en) 2017-07-27
CN106461691A (zh) 2017-02-22
US10234472B2 (en) 2019-03-19
JP6629190B2 (ja) 2020-01-15
EP3151013A1 (en) 2017-04-05
CN111175240A (zh) 2020-05-19
EP3151013A4 (en) 2018-02-21

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